### Competency Overview A competency framework for clinical trial data management, covering what a new research associate must understand, operate, execute, and embody. ### Competency Categories #### Knowledge Competencies - Good clinical practice. - Protocol design fundamentals. - Regulatory submission requirements. #### Technical Competencies - Electronic data capture. - Query management systems. - Statistical validation checks. #### Practical Competencies - Source data verification. - Site monitoring visits. - Audit trail documentation. #### Behavioral Competencies - Detail orientation. - Ethical judgement. - Investigator rapport. ### Competency Relationships Good clinical practice underpins source data verification, which enables disciplined query management, which in turn supports audit-ready trail documentation. ### Proficiency Levels Observer → Assisted Monitor → Independent Monitor → Lead Data Steward ### Development Priorities 1. Good clinical practice. 2. Electronic data capture. 3. Source data verification. 4. Query management. ### Final Competency Map A structured roadmap for developing competence in clinical trial data management, from regulatory grounding to independent oversight.